Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-29 @ 1:08 AM
Study NCT ID:
NCT01421004
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500007', 'term': '4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax', 'timeFrame': '9 days'}], 'secondaryOutcomes': [{'measure': 'Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer', 'timeFrame': 'up to 30 days after the last dose of study drug'}, {'measure': 'Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer', 'timeFrame': 'Every 8 weeks until progression of disease'}]}, 'conditionsModule': {'keywords': ['cancer', 'tumors', 'phase I', 'crossover', 'bioequivalence'], 'conditions': ['Advanced Solid Tumors', 'Excluding Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13570', 'label': 'Results for CTKI258A2128 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists\n2. ECOG performance status (PS) 0, 1 or 2\n3. Patients must meet protocol-specified laboratory values\n\nExclusion Criteria:\n\n1. Patients with brain metastases\n2. Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study\n3. Patients who have not recovered from previous anti-cancer therapies\n4. Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study\n5. Female patients who are pregnant, breast feeding\n6. Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01421004', 'briefTitle': 'Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CTKI258A2128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '500 mg FMI capsule + 250 mg FMI tablet', 'description': 'BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet', 'interventionNames': ['Drug: TKI258']}, {'type': 'EXPERIMENTAL', 'label': '500 mg TKI258 FMI capsule +250 mg FMI tablet', 'description': 'BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule', 'interventionNames': ['Drug: TKI258']}], 'interventions': [{'name': 'TKI258', 'type': 'DRUG', 'otherNames': ['dovitinib'], 'armGroupLabels': ['500 mg FMI capsule + 250 mg FMI tablet', '500 mg TKI258 FMI capsule +250 mg FMI tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center SC-2', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles UCLA LeConte Location', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94101', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco UCSF (SC)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists Sarasota Office', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center Rush 3', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine SC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center Montefiore Medical Center (SC)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center OUHSC - SC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15232-1305', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute Sarah Cannon Research (SC)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Sammons Cancer Center - Texas Oncology SC-2', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah / Huntsman Cancer Institute Huntsman', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Univ Wisc', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Novartitis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartitis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}